Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism (SAGE-2)

Effect of a Reduced Carbohydrates Menu Combined With a Ketogenic Supplement on Energy Metabolism in a Senior Residence: the SAGE-2 Study

The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Dietary supplement: reduced carbohydrate menu combined with ketogenic supplement

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille Vandenberghe; Phone Number: 45235 819-780-2220; Email: camille.vandenberghe@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Centre de recherche sur le vieillissement
      • Contact: Camille Vandenberghe, M.Sc; Phone Number: 45235 819-780-2220; Email: camille.vandenberghe@usherbrooke.ca
      • Principal Investigator: Stephen C Cunnane, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Older men or women in a senior residence;
• Understand, read and write French;
• Have sufficient visual and hearing acuity to pass cognitive tests;
• Available during the intervention period

Exclusion Criteria:

• Body mass index < 20;
• T1 diabetic;
• T2 insulin-dependent diabetic;
• MMSE < 20;
• Weight loss >10% in the last 6 months involuntary or voluntary;
• Known and uncontrolled hypoglycemia;
• Moderate to severe digestive illnesses that can be aggravated by dietary changes;
• Severe dysphagia;
• Supplementation with MCT oil, ketone salts, ketone esters, adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting or other diet or supplements that can significantly increase ketones in the last month;
• Participation in other interventional research projects on nutrition or aimed at metabolic change simultaneously.
• Medical condition that could prevent the participant from completing the study in the opinion of the doctor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delta of before/after the intervention; 2 months of reduced carbohydrate menu combined with a ketogenic MCT supplement	Dietary supplement: reduced carbohydrate menu combined with ketogenic supplement; Participants will eat a reduced carb menu for 2 months and they will take 15g of MCT in the morning and the evening for a total of 30g per day.; Other Names: RCHO+MCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose concentration	To evaluate the possible improvement in mean glucose concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.	2 months
Plasma ketones concentration	To evaluate the possible improvement in mean ketones concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.	2 months
Plasma insulin concentration	To evaluate the possible improvement in mean insulin concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma triglycerides concentration	To evaluate the possible improvement in mean triglycerides concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.	2 months
Plasma cholesterol concentration	To evaluate the possible improvement in mean cholesterol concentration following a reduction in carbohydrates combined with an MCT supplement in people living in a senoir residence for 2 months.	2 months

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Nestle Health Science

Study record dates

Study Major Dates

• Study Start (Estimated): September 5, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ketones; Energy metabolism; Nutritional intervention; Glucose monitoring; Reduced carb diet
• Other Study ID Numbers: 2025-5533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No